Vermillion Tests Not Part of Safety Alert: FDA

Vermillion Labs says it has received a “clarification letter” from CDRH director Jeffrey Shuren stating that a 9/7/16 safety communication advising women and their doctors against using ovarian cancer screening tests for asymptomatic women does not apply to Vermillion’s FDA-cleared OVAI (MIA) and Overa (MIA2G) products, which are not screening tests for ovarian cancer. The letter says the agency cleared the tests “as aids to further assess the likelihood that malignancy is present when the physician’s independent clinical and radiological evaluation does not indicate malignancy. The intended uses of the two assays are the same — to help physicians more reliably identify which patients would benefit from consultation with or referral to a gynecologic oncologist. OVAI (MIA) and Overa (MIA2G) are indicated for women who present with an adnexal mass.”